When offering a healthcare application to the market, the availability of sufficient clinical evidence is paramount. This requirement is regulated by the ISO 14155 Regulation on Clinical investigation of medical devices for human subjects. The matter of evidence base necessary for applications in the Flemish health and care sector is determined by the relevant regulators in this field. For healthcare applications, this is the Federal ministry for Healthcare to contact, for preventive applications this is the Agency for Health and Care XXXX (preventievegezondheidszorg@zorg-en-gezondheid.be ).
Below you can find some general rules regarding evidence based:
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